This site is intended for US healthcare professionals only.

BETHKIS LOGO

Email a colleague

Home/Safety

BETHKIS® (Tobramycin Inhalation Solution)

Concentrated on tolerability and safety

BETHKIS (Tobramycin Inhalation Solution) offers a favorable safety profile

  • High compliance rates across clinical trials1,2
  • Adverse event rates similar to placebo3
  • Generally well tolerated, with a low incidence of voice alteration and bronchospasm1,3
  • Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia

High rates of compliance across clinical trials1,2

Mean treatment compliance across BETHKIS clinical trials
(≥75% of ampules administered)
Phase 2 Trial  98.0%
Phase 3 Trial  98.5%*

*Adjusted mean.

Selected treatment-emergent adverse reactions occurring in ≥2% of BETHKIS patients3

Adverse reactions BETHKIS (n=190) Placebo (n=115)
Forced expiratory volume decreased 59 (31%) 33 (29%)
Rales 36 (19%) 18 (16%)
Red blood cell sedimentation rate increased 16 (8%) 6 (5%)
Dysphonia 11 (6%) 2 (2%)
Wheezing 10 (5%) 4 (4%)
Epistaxis 6 (3%) 0
Pharyngolaryngeal pain 5 (3%) 2 (2%)
Bronchitis 5 (3%) 1 (1%)
Tonsillitis 4 (2%) 0
Diarrhea 3 (2%) 1 (1%)
Eosinophilia 3 (2%) 0
Immunoglobulins increased 3 (2%) 0

The data described in the table above reflect exposure to BETHKIS in 2 placebo-controlled studies in 305 cystic fibrosis patients. Patients receiving BETHKIS ranged in age from 6 to 31 years. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
 

  • In clinical trials, results of assessments for ototoxicity were similar between BETHKIS and placebo, with no reports of tinnitus1
  • Nephrotoxicity was not seen during clinical studies, with serum creatinine levels similar between BETHKIS and placebo groups1

Indication

BETHKIS® (Tobramycin Inhalation Solution) is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.

Important Safety Information

BETHKIS is contraindicated in patients with a known hypersensitivity to any aminoglycoside.

Bronchospasm can occur with inhalation of BETHKIS. Bronchospasm and wheezing should be treated as medically appropriate.

Caution should be exercised when prescribing BETHKIS to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction. Audiograms, serum concentration, and renal function should be monitored as appropriate.

Avoid concurrent and/or sequential use of BETHKIS with other drugs with neurotoxic or ototoxic potential.

BETHKIS should not be administered concurrently with ethacrynic acid, furosemide, urea, or mannitol.

Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.

Fetal harm can occur when aminoglycosides are administered to a pregnant woman. Apprise women of the potential hazard to the fetus.

Common adverse reactions (more than 5%) occurring more frequently in BETHKIS patients are forced expiratory volume decreased, rales, red blood cell sedimentation rate increased, and dysphonia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please see full prescribing information.

 

This website is intended for United States residents only.

References: 1. Chuchalin A, Csiszér E, Gyurkovics K, et al. A formulation of aerosolized tobramycin (Bramitob®) in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection: a double-blind, placebo-controlled, multicenter study. Pediatr Drugs. 2007;9(suppl 1):21-31. 2. Lenoir G, Antypkin YG, Miano A, et al. Efficacy, safety, and local pharmacokinetics of highly concentrated nebulized tobramycin in patients with cystic fibrosis colonized with Pseudomonas aeruginosa. Pediatr Drugs. 2007;9(suppl 1):11-20. 3. BETHKIS [package insert]. Cary, NC: Chiesi USA, Inc.; 2014. 4. Data on file. Chiesi USA, Inc. 5. Poli G, Acerbi D, Pennini R, et al. Clinical pharmacology study of Bramitob, a tobramycin solution for nebulization, in comparison with Tobi®. Pediatr Drugs. 2007;9(suppl 1):3-9.

Are you a patient, caregiver, or healthcare professional?

I AM A PATIENT/CAREGIVER

- or -

I AM A HEALTHCARE PROFESSIONAL